The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Active Psa Irma (dsl-9700).
| Device ID | K973244 |
| 510k Number | K973244 |
| Device Name: | ACTIVE PSA IRMA (DSL-9700) |
| Classification | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Contact | John Class |
| Correspondent | John Class DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Product Code | LTJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-29 |
| Decision Date | 1998-08-03 |
| Summary: | summary |